Tissue harvesting device with manual dicing mechanism

Background

Fistulae can occur for a variety of reasons, such as, from a congenital defect, as a result of inflammatory bowel disease such as Crohn's disease, some sort of trauma, or as a side effect from a surgical procedure. Additionally, several different types of fistulae can occur in humans, for example, urethro-vaginal fistulae, vesico-vaginal fistulae, tracheo-esophageal fistulae, gastrointestinal fistulae, for example gastrocutaneous, enterocutaneous and colocutaneous fistulae, and any number of anorectal fistulae such as recto-vaginal fistula, recto-vesical fistulae, recto-urethral fistulae, and recto-prostatic fistulae. When fistulas form, they can track between intestinal segments or between an intestinal segment and other organs (e.g., bladder, vagina, etc.), adjacent tissue, or the skin. Fistulas are classified as internal when they communicate with adjacent organs (e.g., entero-enteric and rectovaginal fistulas, etc.) and external when they communicate with the dermal surface (e.g., enterocutaneous, peristomal and perianal fistulas, etc.).

Promoting and improving tissue healing around the fistula opening and in the fistula tract may be an important aspect of fistulae medical treatments. For instance, promoting and improving tissue healing may lead to quicker recovery times and lessen the opportunity for infection, particularly in a post-surgical context. Some advancements in the medical arts pertaining to systems, methods, and devices to promote and improve tissue healing in patients aim to add active biological components (e.g., tissue particles, stem cells, other types of cells, etc.) to a wound site (e.g., surgical site, accidental trauma site, etc.) or other defect site (e.g., caused by disease or other condition, etc.) to promote tissue regeneration or accelerate tissue healing. When adding biological components to a site, such components may be added independently or as part of a specifically designed matrix or other mixture depending on the condition being treated and goals of the treatment. Some examples of cell-based therapy technology are disclosed in U.S. Pub. No. 2008/0311219, entitled "Tissue Fragment Compositions for the Treatment of Incontinence," published Dec. 18, 2008, the disclosure of which is incorporated by reference herein. Additional examples of cell-based therapy technology are disclosed in U.S. Pub. No. 2004/0078090, entitled "Biocompatible Scaffolds with Tissue Fragments," published Apr. 22, 2004, the disclosure of which is incorporated by reference herein. Additional examples of cell-based therapy technology are disclosed in U.S. Pub. No. 2008/0071385, entitled "Conformable Tissue Repair Implant Capable of Injection Delivery," published Mar. 20, 2008, the disclosure of which is incorporated by reference herein.

Regardless of how the active biological components are delivered or applied to a site, the biological components must first be obtained and prepared. One approach for obtaining such biological components is to harvest the desired components from a healthy tissue specimen (e.g., in an adult human). Examples of devices and associated methods for collecting and processing harvested tissue are disclosed in U.S. Pub. No. 2004/0193071, entitled "Tissue Collection Device and Methods," published Sep. 30, 2004, the disclosure of which is incorporated by reference herein. Additional examples of devices and associated methods for collecting and processing harvested tissue are disclosed in U.S. Pub. No. 2005/0038520, entitled "Method and Apparatus for Resurfacing an Articular Surface," published Feb. 17, 2005, the disclosure of which is incorporated by reference herein. Additional examples of devices and associated methods for collecting and processing harvested tissue are disclosed in U.S. Pat. No. 7,611,473, entitled "Tissue Extraction and Maceration Device," issued Nov. 3, 2009, the disclosure of which is incorporated by reference herein. Additional examples of devices and associated methods for collecting and processing harvested tissue are disclosed in U.S. Pub. No. 2008/0234715, entitled "Tissue Extraction and Collection Device," published Sep. 25, 2008, the disclosure of which is incorporated by reference herein. Additional examples of devices and associated methods for processing harvested tissue are disclosed in U.S. Pub. No. 2005/0125077, entitled "Viable Tissue Repair Implants and Methods of Use," published Jun. 9, 2005, the disclosure of which is incorporated by reference herein. Additional examples of devices and associated methods for collecting and processing harvested tissue are disclosed in U.S. Pat. No. 5,694,951, entitled "Method for Tissue Removal and Transplantation," issued Dec. 9, 1997, the disclosure of which is incorporated by reference herein. Additional examples of devices and associated methods for collecting and processing harvested tissue are disclosed in U.S. Pat. No. 6,990,982, entitled "Method for Harvesting and Processing Cells from Tissue Fragments," issued Jan. 31, 2006, the disclosure of which is incorporated by reference herein. Additional examples of devices and associated methods for collecting and processing harvested tissue are disclosed in U.S. Pat. No. 7,115,100, entitled "Tissue Biopsy and Processing Device," issued Oct. 3, 2006, the disclosure of which is incorporated by reference herein.

Once harvested and suitably processed (e.g., incorporated with a scaffold, etc.), biological material such as tissue fragments may be applied to a wound site or other type of site within the human body in a variety of ways. Various methods and devices for applying such biological material are disclosed in one or more of the U.S. patent references cited above. Additional methods and devices for applying such biological material are disclosed in U.S. Pub. No. 2005/0113736, entitled "Arthroscopic Tissue Scaffold Delivery Device," published May 26, 2005, the disclosure of which is incorporated by reference herein.

While a variety of devices and techniques may exist for harvesting, processing, and applying biological components from a tissue specimen, it is believed that no one prior to the inventor(s) has made or used an invention as described herein.

Brief description of the drawings

While the specification concludes with claims which particularly point out and distinctly claim the invention, it is believed the present invention will be better understood from the following description of certain examples taken in conjunction with the accompanying drawings. In the drawings, like numerals represent like elements throughout the several views.

FIG. 1 depicts a perspective view of an exemplary version of a standalone tissue dicing device.

FIG. 2 depicts a perspective view of the tissue dicing device of FIG. 1 in operation.

FIG. 3 depicts a side cross-sectional view of a grid cutting element of the tissue dicing device of FIG. 1 in operation.

FIG. 4 depicts a perspective view of the tissue dicing device of FIG. 1 with a diced tissue tray removed.

FIG. 5 depicts a system schematic view of an exemplary tissue harvesting device with an integrated dicing mechanism.

FIG. 6 depicts a partial perspective view of an exemplary tissue harvesting device with an integrated dicing mechanism.

FIG. 7 depicts a partial perspective view of the tissue harvesting device of FIG. 6 in operation.

FIG. 8 depicts a perspective view of an exemplary self-expanding fistula plug creation and delivery system, shown in a first stage of an exemplary process.

FIG. 9 depicts a perspective view of the self-expanding fistula plug creation and delivery system of FIG. 8, shown in a second stage of the process.

FIG. 10 depicts a perspective view the self-expanding fistula plug creation and delivery system of FIG. 8, shown in a third stage of the process.

FIG. 11 depicts a perspective view of the self-expanding fistula plug creation and delivery system of FIG. 8, shown in a fourth stage of the process.

FIG. 12 depicts a perspective view of the self-expanding fistula plug creation and delivery system of FIG. 8, shown in a fifth stage of the process.

FIG. 13 depicts a perspective view of the self-expanding fistula plug creation and delivery system of FIG. 8, shown in a sixth stage of the process.

The drawings are not intended to be limiting in any way, and it is contemplated that various embodiments of the invention may be carried out in a variety of other ways, including those not necessarily depicted in the drawings. The accompanying drawings incorporated in and forming a part of the specification illustrate several aspects of the present invention, and together with the description serve to explain the principles of the invention; it being understood, however, that this invention is not limited to the precise arrangements shown.

Detailed description

The following description of certain examples should not be used to limit the scope of the present invention. Other features, aspects, and advantages of the versions disclosed herein will become apparent to those skilled in the art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the versions described herein are capable of other different and obvious aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.

I. Overview of Exemplary Treatment Compositions, Devices, and Methods

Examples described herein include devices that are operable to harvest tissue, mince or morcellate tissue, and/or dispense a medical fluid at a target site in a patient. As described in greater detail below, the medical fluid may include any of a variety of biocompatible materials that accelerate tissue healing, promote tissue regeneration, and/or provide other results. As used herein, the terms "tissue treatment composition," "tissue repair composition," and "medical fluid" should be read interchangeably. It should also be understood that a tissue treatment composition or medical fluid as referred to herein may have any suitable consistency, including but not limited to the consistency of a slurry.

A medical fluid as referred to herein may be derived from any biocompatible material, including but not limited to synthetic or natural polymers. The consistency of the medical fluid may be viscous, or gel-like, that of a slurry composed of microparticles, or any other suitable consistency. By way of example only, any fluid consistency that may permit injection through a catheter may be used. The medical fluid may also provide adhesive characteristics, such that once it is injected at a target site (e.g., into a fistula), the fluid coagulates or gels (e.g., allowing for a plug to be retained within a fistula). The medical fluid of the present example is also able to support cell migration and proliferation such that healing at a target site in a patient can occur. The fluid is suitable to be mixed with biological materials. Examples of medical fluid components include but are not limited to thrombin, platelet poor plasma (PPP) platelet rich plasma (PRP), starch, chitosan, alginate, fibrin, polysaccharide, cellulose, collagen, gelatin-resorcin-formalin adhesive, oxidized cellulose, mussel-based adhesive, poly (amino acid), agarose, amylose, hyaluronan, polyhydroxybutyrate (PHB), hyaluronic acid, poly(vinyl pyrrolidone) (PVP), poly(vinyl alcohol) (PVA), polylactide (PLA), polyglycolide (PGA), polycaprolactone (PCL), and their copolymers, VICRYL.RTM. (Ethicon, Inc., Somerville, N.J.), MONOCRYL material, PANACRYL (Ethicon, Inc., Somerville, N.J.), and/or any other material suitable to be mixed with biological material and introduced to a wound or defect site, including combinations of materials. Other suitable compounds, materials, substances, etc., that may be used in a medical fluid will be apparent to those of ordinary skill in the art in view of the teachings herein.

By way of example only, one or more components in a medical fluid or tissue treatment composition may comprise at least one viable tissue fragment having one or more viable cells that, once applied, can proliferate and integrate with tissue at a target site in a patient. For instance, viable cells may migrate out of a tissue particle and populate a scaffold material, which may be positioned at a target site in a patient. Such tissue fragments may have been harvested from the same patient in whom they are reapplied; or may have been harvested from another person or source. The tissue fragments may comprise autogenic tissue, allogenic tissue, xenogenic tissue, mixtures of any of the foregoing, and/or any other type(s) of tissue. The tissue fragments may include, for example, one or more of the following tissues or tissue components: stem cells, cartilage tissue, meniscal tissue, ligament tissue, tendon tissue, skin tissue, muscle tissue (e.g., from the patient's thigh, etc.), periosteal tissue, pericardial tissue, synovial tissue, fat tissue, bone marrow, bladder tissue, umbilical tissue, embryonic tissue, vascular tissue, blood and combinations thereof. Of course, any other suitable type of tissue may be used, including any suitable combination of tissue types. In some versions, the type of tissue used is selected from a tissue type most resembling the tissue at, near, or surrounding the target site (e.g., fistula, etc.).

Tissue for providing at least one viable tissue fragment may be obtained using any of a variety of tissue biopsy devices or using other types of tissue harvesting devices or techniques. Exemplary biopsy devices include those taught in U.S. Pat. No. 5,526,822, entitled "Method and Apparatus for Automated Biopsy and Collection of Soft Tissue," issued Jun. 18, 1996; U.S. Pat. No. 6,086,544, entitled "Control Apparatus for an Automated Surgical Biopsy Device," issued Jul. 11, 2000; U.S. Pub. No. 2007/0118048, entitled "Remote Thumbwheel for a Surgical Biopsy Device," published May 24, 2007, and issued Oct. 28, 2008 as U.S. Pat. No. 7,442,171; U.S. Pub. No. 2008/0214955, entitled "Presentation of Biopsy Sample by Biopsy Device," published Sep. 4, 2008; U.S. Non-Provisional patent application Ser. No. 12/337,942, entitled "Biopsy Device with Central Thumbwheel," filed Dec. 18, 2008, and published Jun. 24, 2010 as U.S. Pub. no. 2010/0160819; and U.S. Non-Provisional patent application Ser. No. 12/483,305, entitled "Tetherless Biopsy Device with Reusable Portion," filed Jun. 12, 2009, and issued Jun. 26, 2012 as U.S. Pat. No. 8,206,316. The disclosure of each of the above-cited U.S. patents, U.S. patent application Publications, and U.S. Non-Provisional patent applications is incorporated by reference herein. Such biopsy devices may be used to extract a plurality of tissue specimens from one or more sites in a single patient. It should also be understood that any suitable device described in any other reference that is cited herein may be used to harvest tissue. Additional examples of devices that may be used to harvest tissue will be described in greater detail below. Other examples will be apparent to those of ordinary skill in the art in view of the teachings herein. Tissue harvesting sites may include the same sites in which tissue is reapplied as part of a treatment. In addition or in the alternative, tissue may be harvested from one site and then reapplied at some other site as part of a treatment. In some versions, the tissue is reapplied in the same patient from whom the tissue was originally harvested. In some other versions, the tissue is applied in a patient who is different from the patient from whom the tissue was originally harvested.

A tissue specimen may be obtained under aseptic conditions, and then processed under sterile conditions to create a suspension having at least one minced, or finely divided, tissue fragment. In other words, harvested tissue may be diced, minced or morcellated, and/or otherwise processed. Harvested tissue specimens may be minced and otherwise processed in any of a variety of ways. For instance, examples of tissue mincing and processing are described in U.S. Pub. No. 2004/0078090, the disclosure of which is incorporated by reference herein. Alternatively, merely exemplary non-conventional devices and techniques that may be used to mince and process tissue will be described in greater detail below, while other examples will be apparent to those of ordinary skill in the art in view of the teachings herein. In order to ensure viability of the tissue, agitators or other features of a mincing and/or mixing device may be designed to sever and mix (rather than crush or compress) the tissue. In some settings, tissue specimens may be minced and/or mixed in a standard cell culture medium, either in the presence or absence of serum. Tissue fragments may also be contacted with a matrix-digesting enzyme to facilitate cell migration out of an extracellular matrix surrounding the cells. Suitable matrix-digesting enzymes that may be used in some settings include, but are not limited to, collagenase, chondroitinase, trypsin, elastase, hyaluronidase, peptidase, thermolysin, and protease. The size of each tissue fragment may vary depending on the target location, method for delivering the treatment composition to the target site, and/or based on various other considerations. For example, the tissue fragment size may be chosen to enhance the ability of regenerative cells (e.g., fibroblasts) in the tissue fragments to migrate out of the tissue fragments, and/or to limit or prevent the destruction of cell integrity. In some settings, ideal tissue fragments are between approximately 200 microns and approximately 500 microns in size. As another merely illustrative example, ideal tissue fragments may be sized within the range of approximately 0.05 mm.sup.3 and approximately 2 mm.sup.3; or more particularly between approximately 0.05 mm.sup.3 and approximately 1 mm.sup.3. Of course, various other tissue fragment sizes may be ideal in various different settings.

In some versions, a medical fluid may comprise minced tissue fragments suspended in a biocompatible carrier. Suitable carriers may include, for example, a physiological buffer solution, a flowable gel solution, saline, and water. In the case of gel solutions, the tissue repair composition may be in a flowable gel form prior to delivery at the target site, or may form a gel and remain in place after delivery at the target site. Flowable gel solutions may comprise one or more gelling materials with or without added water, saline, or a physiological buffer solution. Suitable gelling materials include biological and synthetic materials. Exemplary gelling materials include the following: proteins such as collagen, collagen gel, elastin, thrombin, fibronectin, gelatin, fibrin, tropoelastin, polypeptides, laminin, proteoglycans, fibrin glue, fibrin clot, platelet rich plasma (PRP) clot, platelet poor plasma (PPP) clot, self-assembling peptide hydrogels, Matrigel or atelocollagen; polysaccharides such as pectin, cellulose, oxidized regenerated cellulose, chitin, chitosan, agarose, or hyaluronic acid; polynucleotides such as ribonucleic acids or deoxyribonucleic acids; other materials such as alginate, cross-linked alginate, poly(N-isopropylacrylamide), poly(oxyalkylene), copolymers of poly(ethylene oxide)-poly(propylene oxide), poly(vinyl alcohol), polyacrylate, or monostearoyl glycerol co-Succinate/polyethylene glycol (MGSA/PEG) copolymers; and combinations of any of the foregoing. In addition to providing a flowable carrier solution for tissue fragments, a gelling agent(s) may also act as an adhesive that anchors the tissue repair composition at the target site. In some versions, an additional adhesive anchoring agent may be included in the tissue repair composition or medical fluid. Also, one or more cross-linking agents may be used in conjunction with one or more gelling agents in order to cross-link the gelling agent.

The concentration of tissue fragments in a carrier and/or one or more medical fluid components may vary depending on the target site location, method for delivering the treatment composition to the target site, and/or for various other reasons. By way of example, the ratio of tissue fragments to carrier (by volume) may be in the range of about 2:1 to about 6:1, or in the range of about 2:1 to about 3:1. The medical fluid may also include one more additional healing agents, such as biological components that accelerate healing and/or tissue regeneration. Such biological components may include, for example, growth factors, proteins, peptides, antibodies, enzymes, platelets, glycoproteins, hormones, cytokines, glycosaminoglycans, nucleic acids, analgesics, viruses, isolated cells, or combinations thereof. The medical fluid may further include one or more additional treatment components that prevent infection, reduce inflammation, prevent or minimize adhesion formation, and/or suppress the immune system. In some versions where a scaffold is used in conjunction with a tissue treatment composition, one or more of these additional biological components or additional treatment components may be provided on and/or within the scaffold. Similarly, in some versions where a scaffold plug is used in conjunction with a tissue repair composition, one or more of these additional biological components or additional treatment components may be provided on and/or within the scaffold plug. Some examples described herein may also include one or more adhesive agents in conjunction with viable tissue fragments.

As noted above, the harvested tissue may be combined with a scaffold material and/or other substances as part of a medical fluid, as described herein, for administration to the patient. To the extent that tissue is incorporated with a scaffold material, it should be understood that any suitable material or combination of materials may be used to provide a scaffold. By way of example only, scaffold material may include a natural material, a synthetic material, a bioabsorbable polymer, a non-woven polymer, other types of polymers, and/or other types of materials or combinations of materials. Examples of suitable biocompatible materials include starch, chitosan, cellulose, agarose, amylose, lignin, hyaluronan, alginate, hyaluronic acid, fibrin glue, fibrin clot, collagen gel, gelatin-resorcin-formalin adhesive, platelet rich plasma (PRP) gel, platelet poor plasma (PPP) gel, Matrigel, Monostearoyl Glycerol co-Succinate (MGSA), Monostearoyl Glycerol co-Succinate/polyethylene glycol (MGSA/PEG) copolymers, laminin, elastin, proteoglycans, polyhydroxybutyrate (PHB), poly(vinyl pyrrolidone) (PVP), polylactide (PLA), polyglycolide (PGA), polycaprolactone (PCL), and their copolymers, non-woven VICRYL.RTM. (Ethicon, Inc., Somerville, N.J.), MONOCRYL material, fibrin, non-woven poly-L-lactide, and non-woven PANACRYL (Ethicon, Inc., Somerville, N.J.). Polymers may include aliphatic polyesters, poly(amino acids), copoly(ether-esters), polyalkylenes oxalates, polyamides, tyrosine derived polycarbonates, poly(iminocarbonates), polyorthoesters, polyoxaesters, polyamidoesters, polyoxaesters containing amine groups, poly(anhydrides), polyphosphazenes, poly(propylene fumarate), polyurethane, poly(ester urethane), poly(ether urethane), and blends and copolymers thereof. Suitable synthetic polymers for use in examples described herein may also include biosynthetic polymers based on sequences found in collagen, laminin, glycosaminoglycans, elastin, thrombin, fibronectin, starches, poly(amino acid), gelatin, alginate, pectin, fibrin, oxidized cellulose, chitin, chitosan, tropoelastin, hyaluronic acid, silk, ribonucleic acids, deoxyribonucleic acids, polypeptides, proteins, polysaccharides, polynucleotides, and combinations thereof. Other suitable materials or combinations of materials that may be used will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that tissue mixed with a scaffold material may have any suitable particle size, and that the resulting mixture may at least initially have the consistency of a slurry or have any other suitable consistency. In some versions, the tissue particles include an effective amount of viable cells that can migrate out of the tissue particle and populate the scaffold. The term "viable," as used herein, should be understood to include a tissue sample having one or more viable cells.

In some versions, one or more components in a medical fluid or tissue treatment composition comprise one or more healing agents that promote tissue regeneration at a target site (e.g., within a fistula) and/or accelerate tissue healing at the target site. Healing agents may include any of a variety of biocompatible materials that accelerate tissue healing and/or promote tissue regeneration. Such biological components may include, for example, growth factors, proteins, peptides, antibodies, enzymes, platelets, glycoproteins, hormones, cytokines, glycosaminoglycans, nucleic acids, analgesics, viruses, isolated cells, or combinations thereof. The medical fluid may further include one or more additional treatment components that prevent infection, reduce inflammation, prevent or minimize adhesion formation, and/or suppress the immune system. In some versions where a scaffold is used in conjunction with a tissue treatment composition, one or more of these additional biological components or additional treatment components may be provided on and/or within the scaffold. Some examples described herein may also include one or more adhesive agents in conjunction with viable tissue fragments.

Examples described herein relate to the repair (e.g., closing) of lumens in a patient, such as anal fistulas and other types of fistulas. In particular, examples described herein include devices used in at least part of a process to create and/or deliver tissue repair compositions or medical fluid into a lumen such as an anal fistula. It should be understood that anal fistulas and/or other types of fistulas may be relatively difficult to repair (e.g., close) in some settings. The goal of a surgical repair of an anal fistula may be to close the fistula with as little impact as possible on the sphincter muscles. In some settings, a tissue repair composition or medical fluid as described herein may be delivered into the fistula as a liquid composition, a flowable gel or paste, a scaffold plug, or a combination of the two or more of the foregoing (e.g., a porous scaffold plug loaded with a medical fluid composition, etc). Anal fistulas may also be repaired by injecting bioresorbable fibrin glue into the fistula that seals the fistula and promotes tissue growth across the fistula in order to provide permanent closure. Various bioresorbable plugs may also be used to repair anal fistulas. The plug may comprise, for example, collagen protein, tissue, stem cells, and/or other medical fluid components referred to herein; and the plug may be inserted into the fistula where it promotes tissue growth across the fistula as the plug dissolves. If desired, the plug may be secured in place using one or more fasteners and/or one or more adhesive agents. As another merely illustrative example, a medical fluid may be introduced within the fistula, and the medical fluid may eventually harden and then dissolve and/or be absorbed.

Prior to applying a medical fluid to a fistula, it may be desirable in some settings to debride the wall of a fistula (e.g., to remove epithelial cells, etc.), otherwise agitate the wall of the fistula, and/or otherwise treat the walls of the fistula. While examples herein are discussed in the context of an anorectal fistula, it should be understood that the following exemplary devices and techniques may be readily applied to various other types of fistulae. Similarly, while the present example relates to treatment of a fistula in a patient, it should also be understood that the following exemplary devices and techniques may be readily applied with respect to various other types of conditions in a patient. Other suitable ways in which the devices and techniques described herein may be used will be apparent to those of ordinary skill in the art in view of the teachings herein.

As used herein, the term "fluid communication" (or in some contexts "communication") means that there is a path or route through which fluid (gas, liquid or other flowable material) may flow between two components, either directly or through one or more intermediate components. Similarly, the term "conduit" encompasses a conduit within or integrated with a valve. In other words, fluid communication between two components means that fluid can flow from one component to another but does not exclude an intermediate component (e.g., a valve, etc.) between the two recited components that are in fluid communication. Similarly, two or more components may be in mechanical "communication" with each other even if intermediate components are interposed between those two or more components.

II. Exemplary Tissue Dicing Device

FIGS. 1-4 depict an example of a standalone tissue dicing device

that is operable to process tissue specimens

by cutting the tissue specimens

into diced tissue (25). Tissue dicing device

of this example comprises a housing (10), a grid cutting element (12), and a dicing chamber (21). A tray

is provided below dicing chamber (21). As will be described in greater detail below, grid cutting element

is operable to dice tissue in dicing chamber (21), leaving diced tissue

on tray

for subsequent removal of diced tissue

on tray (16). Tissue dicing device

further includes a door panel (14), a menu selector (18), and a cutting board (20). As shown in FIG. 1, a coring biopsy needle

may be used to deposit tissue specimens

on cutting board

in dicing chamber (21). Biopsy needle

may comprise a conventional coring biopsy needle having an open distal end. For instance, biopsy needle

may include a plunger (not shown) that may be retracted to extract a tissue specimen

from a patient and then advanced to deposit the tissue specimen

on cutting board (20). Of course, a variety of other types of instruments may be used to harvest tissue specimens

from a patient and/or deposit tissue specimens

on cutting board (20), including but not limited to various other devices described herein, described in any of the U.S. patents cited herein, described in any of the U.S. patent application Publications cited herein, or described in any of the U.S. Non-Provisional patent applications cited herein.

Grid cutting element

of the present example comprises a series of blades

that are oriented to form a grid. Of course, blades

may be provided in various other arrangements as well (e.g., a series of parallel blades, a pyramidal arrangement, a series of staggered blades, etc.). Blades

are fixedly mounted to door panel (14), which is pivotably coupled with housing (10). Each blade

has a sharpened edge that is configured to cut through tissue specimens (24). Such sharpened edges may include teeth at various pitches, various other serrated edges, and/or various other configurations. In addition, blades

and/or door panel

may be configured to allow the density of the blade arrangement to be varied so that tissue specimens

may be selectively cut to a particular desired size. Various suitable ways in which tissue dicing device

may provide selective variability of the density and/or arrangement of blades

will be apparent to those of ordinary skill in the art in view of the teachings herein. Blades

may be made from a sheet metal material, such as stainless steel, or any other suitable material or combination of materials.

In the present example, cutting board

is a removable item that has a smooth surface against which blades

cut tissue specimens

into diced tissue (25). FIG. 2 shows door panel (14), having grid cutting element

attached thereto, pivotably closing onto tissues samples

on the cutting board (20). FIG. 3 shows a side view of door panel (14), having grid cutting element

attached thereto, closed onto the tissues specimens

on cutting board (20), with grid cutting element

dicing tissue specimens

into diced tissue (25). Cutting board

may be manufactured from a material having elastomeric properties and/or various other properties. By way of example only, cutting board

may be formed of polyethylene, polypropylene, metal, or wood-based materials, etc. and/or various combinations of materials. In the present example, after tissue specimens

are cut into diced tissue (25), cutting board

is removed and diced tissue

drops onto tray (16), which is located below cutting board (20). As shown in FIG. 4, tray

may then be removed from housing

and be used to transport diced tissue

to another location and/or device for further processing/use. Tray

may also be manufactured from a material having elastomeric properties and/or various other properties, including but not limited to polyethylene, polypropylene, metal, or wood-based materials, etc. and/or various combinations of materials.

In some versions, cutting board

may slide away into a recess (not shown) within the housing

after tissue specimens

have been cut into diced tissue (25). When this occurs, diced tissue

may be scraped or wiped off cutting board

and onto the tray

below as cutting board

retracts. For instance, diced tissue

may be scraped off by a scraper (not shown), a wiper (not shown), or by a wall (not shown) within housing

at the perimeter of cutting chamber (21). In addition or in the alternative, cutting board

may fold away or flap open like a trap door to allow diced tissue

fall onto the tray (16). Various other suitable ways in which diced tissue

may be transferred from cutting board

to tray

will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that tray

itself may be used as a cutting board in some versions, such that a separate cutting board

may be omitted. In other words, coring biopsy needle

(or some other device) may be used to deposit tissue specimens

directly onto tray (16), and blades

may cut tissue specimens

into diced tissue

directly on tray (16).

In the present example, menu selector

allows a user to choose from various pre-programmed options. Menu selector

may include one or more buttons, switches, displays, and/or various other types of user input/interface features. Options that may be selected from using menu selector

may include powering tissue dicing device

off and on, selecting the number of times to chop tissue specimens

so as to obtain a fine cut diced tissue (25), vary the density of the arrangement of blades (13), and/or otherwise vary the arrangement of blades (13). Other options that may be selected using menu selector

will be apparent to those of ordinary skill in the art in view of the teachings herein. It should also be understood that, like other components and features described herein, menu selector

may be omitted entirely if desired.

In some merely illustrative variations, grid cutting element

is not integrally incorporated into door panel (14). For instance, door panel

may instead present a plate (not shown) where grid cutting element

would otherwise be located. Cutting element

may instead be mounted to housing

at a position between the plate of door panel

and tray (16), or may be provided in any other suitable location. Tissue specimens

may be placed directly on cutting element

in some such versions. As the door panel

is closed, the plate of door panel

may push tissue specimens

against the edges of blades

of cutting element (12), providing diced tissue (25). Such diced tissue

may then drop into tray

located below grid cutting element (12). Other suitable components, features, configurations, and operabilities of tissue dicing device

will be apparent to those of ordinary skill in the art in view of the teachings herein.

III. Exemplary Tissue Harvesting and Dicing Device

While tissue dicing device

of FIGS. 1-4 is a stand-alone device that is separate from the device used to harvest tissue specimens (24), it should be understood that tissue dicing capabilities may be incorporated as an integral feature of a tissue harvesting device. For instance, FIG. 5 depicts an exemplary tissue harvesting device

having an integral tissue dicing mechanism (114). As shown in FIG. 5, tissue harvesting device

of this example comprises a needle

and a tissue collection body (110). Needle

of this example has a closed, tissue piercing tip

and a side aperture

located proximal to tip (106). An inner cutter

is slidably and rotatably positioned within needle

and may be rotated and advanced distally within needle

to sever tissue protruding through side aperture

when needle

is inserted in a patient. Tissue collection body

includes a cutter actuation mechanism (116), a vacuum source (112), a tubular knock out pin (120), and a dicing mechanism (114). FIG. 5 also shows a tissue specimen

as it moves through tissue harvesting device (100). Tubular knock out pin

is positioned coaxially within inner cutter (108), and is configured to maintain a substantially constant position relative to tissue collection body

even while inner cutter

moves relative to tissue collection body (110). Knock out pin

is positioned adjacent to dicing mechanism (114), and is configured to push tissue specimen

out through the open distal end of inner cutter

into dicing mechanism

as inner cutter

is retracted proximally relative to knock out pin (120). Dicing mechanism

may be configured in accordance with the various teachings of tissue dicing mechanisms herein.

Cutter actuation mechanism

is operable to selectively advance and retract inner cutter

relative to tissue collection body (110), and may be configured in accordance with the teachings of any U.S. patent, U.S. patent application Publication, or U.S. Non-Provisional patent application cited herein; or may have any other suitable configuration. Vacuum source

is operable to draw a vacuum through needle (102). Such a vacuum may assist in drawing tissue into side aperture (104). Vacuum source

may also be operable to draw a vacuum through cutter (108), which may assist in carrying tissue specimen

proximally relative to needle (102). While vacuum source

is shown as being an integral component of tissue collection body (110), it should be understood that vacuum source

may instead be located external to tissue collection body (110). For instance, vacuum source

may be coupled with needle

and/or some other component of tissue harvesting device

via one or more conduits, etc.

In an example of operating tissue harvesting device (100), an operator may insert needle

into a patient at any suitable location (e.g., in the patient's thigh muscle). Inner cutter

may be located at a distal position, effectively "closing off" side aperture

during such insertion. Inner cutter

is then retracted upon sufficient insertion of needle

and vacuum source

is activated to draw tissue into side aperture (104). Inner cutter

is then advanced distally past side aperture

to sever tissue specimen

from tissue protruding through side aperture (104). Tissue specimen

is then positioned inside of inner cutter (108). Inner cutter

is then retracted proximally Tissue specimen

moves proximally with cutter until tissue specimen

engages knock out pin (120). Inner cutter

continues to retract as tissue specimen

engages knock out pin (120), such that knock out pin

eventually pushes tissue specimen

out through the open distal end of inner cutter (108). Tissue specimen

then drops into dicing mechanism (114). As will be described in greater detail below, dicing mechanism

then dices tissue specimen (118).

It should be understood from the foregoing that at least part of tissue harvesting device

may be constructed like a conventional biopsy device that would be used for excising soft tissue specimens. By way of example only, at least part of tissue harvesting device

The description continues in the full USPTO document.